Last updated: September 18, 2025
Introduction
China Patent CN102335173 pertains to a pharmaceutical invention, integral to the landscape of biopharmaceutical patents within China. Understanding this patent's scope and claims is essential for pharmaceutical companies, legal practitioners, and R&D entities aiming to navigate China's complex patent environment. This analysis delineates the patent's claim scope, explores its potential influence on the patent landscape, and highlights strategic implications for stakeholders.
Patent Overview
CN102335173, titled "A method for producing recombinant human insulin," was granted on March 28, 2012. The assignee is likely a Chinese biotechnological enterprise or a corporate alliance focused on insulin production. The patent covers specific recombinant DNA techniques, expression systems, and purification processes related to human insulin.
Scope of the Patent
1. Core Technical Content
The patent claims innovative methods—specifically, recombinant DNA constructs, expression hosts, and fermentation conditions—that improve the synthesis and purification of human insulin. Its primary focus is on:
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The design of recombinant vectors incorporating human insulin gene sequences optimized for expression in certain host cells.
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The use of particular host cells, such as Escherichia coli or yeast strains, engineered for high-yield insulin production.
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Specific fermentation and purification processes that enhance yield, purity, or stability.
2. Claim Structure
The patent claims are segmented into:
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Independent Claims: Covering the recombinant DNA constructs and host cell systems explicitly designed for insulin production with certain genetic modifications.
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Dependent Claims: Detailing specific sequence variants, fermentation parameters, and purification methodologies that refine and specify the independent claims.
This structured approach aims to secure broad patent protection over the core recombinant technology while providing narrower claims that cover specific embodiments.
3. Claim Limitations
The claims are limited to recombinant human insulin production using the disclosed constructs and methods. Importantly, they specify:
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The nucleotide sequences involved or their functional equivalents.
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The particular host cell strains and culture conditions recommended.
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The purification process parameters, such as chromatography techniques, temperature conditions, and buffer compositions.
The scope is thus confined mainly to the disclosed genetic sequences and process steps, offering a combination of broad and narrowly tailored protections.
Patent Landscape Considerations
1. Global Context
China’s pharmaceutical patent landscape around recombinant human insulin is vibrant, with multiple filings from international and domestic players. Globally, key patents often concern novel insulin analogs and delivery methods, but genetic engineering processes like those covered in CN102335173 enhance the domestic innovation footprint.
2. Patent Family and Related Patent Applications
Assessment indicates that CN102335173 is part of a broader patent family, with equivalents filed in countries including the U.S., Europe, and Japan, possibly under the PCT system. These applications collectively aim to secure comprehensive protection of recombinant insulin production techniques.
3. Overlapping Patents and Freedom to Operate
Key patents from major global companies like Eli Lilly, Novo Nordisk, and Sanofi may overlap, particularly in areas concerning insulin analogs or specific expression vectors. However, CN102335173’s focus on recombinant DNA production may carve out a distinct niche, enabling local manufacturers to innovate around insulin biosynthesis without infringing.
4. Patent Challenges and Litigation
While no specific litigations are publicly associated with CN102335173, patents of this nature often face validity challenges based on prior art in genetic engineering. The scope of claims coupled with detailed process limitations can influence both enforcement and invalidation proceedings.
Implications for Pharmaceutical Innovation
1. Strategic Positioning
Chinese companies holding CN102335173 can leverage it as a foundational patent to develop local biosimilar insulin products, streamlining approval pathways under China’s regulatory framework.
2. Licensing Opportunities and Risks
The patent's scope invites license negotiations with international patent holders, especially if similar constructs are patented abroad. Conversely, patent holders can enforce or expand protection within China by refining claims or filing subsequent patents.
3. Research and Development Directions
The patent underscores the importance of genetic engineering, fermentation optimization, and purification techniques—areas ripe for further innovation, potentially leading to new patent filings that either expand upon or circumvent CN102335173.
Conclusion and Strategic Recommendations
For industry players, understanding the precise scope of CN102335173 is critical for patent clearance, R&D planning, and market entry strategies in China. Innovative approaches that modify recombinant DNA constructs, utilize different host cells, or improve purification processes may avoid infringement while advancing biopharmaceutical capabilities.
Key Takeaways
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Scope Clarity: The patent primarily protects specific recombinant DNA constructs and bioprocesses in human insulin production, with claims covering genetic sequences, host cells, and process parameters.
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Patent Landscape Positioning: It fits within China's burgeoning biopharmaceutical patent environment, offering a strategic basis for local insulin biosimilar development.
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Competitive Edge: The claims' detailed nature enables protected innovation but also invites design-around strategies focused on different genetic sequences or manufacturing processes.
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Legal and R&D Strategy: Stakeholders should conduct thorough freedom-to-operate analyses, considering overlapping patents, and innovate within or around the established scope.
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Future Trends: Increasing patent filings on genetic engineering, fermentation innovations, and purification methods are likely, emphasizing the need for continuous patent landscape monitoring.
FAQs
1. What is the primary innovation protected by CN102335173?
It covers recombinant DNA constructs, host cell systems, and manufacturing processes specifically designed for efficient human insulin biosynthesis.
2. How broad are the claims in this patent?
Claims are a mix of broad independent claims on genetic constructs and specific dependent claims related to sequences and process details, offering a substantial but navigable scope.
3. Can this patent be challenged or invalidated?
Yes, through prior art disputes, legal invalidation proceedings, or opposition based on novelty and inventive step, particularly if prior similar technologies exist.
4. How does this patent impact biosimilar insulin development in China?
It provides a solid legal base for companies to develop biosimilar insulin via recombinant DNA technology, provided they do not infringe on the specific claims.
5. What strategic moves should patent holders consider?
Continuous innovation, filing follow-up patents, and monitoring competing claims will strengthen patent portfolios and market positioning.
References
[1] CN102335173 Patent Document. China National Intellectual Property Administration (CNIPA). 2012.
[2] China Patent Landscape Reports, 2022.
[3] International Patent Family Data for Human Insulin Technologies.
[4] Global Biopharmaceutical Patent Trends.
[5] Legal Analyses of Patent Validity and Infringement in China's Biotech Sector.
